The Phase I trial that began is being conducted is the first stage of human testing, and aims to evaluate safety. The trial will take 15 months to complete and will enrol 30 volunteers, men and women, who are in good health and HIV negative.
The vaccine candidate tgAAC09 is modelled after subtype C of HIV, the subtype that accounts for the most infections worldwide and is prevalent in many developing countries, including India and South Africa. It is designed so that it cannot cause HIV infection or AIDS, it consists of an artificially made copy of a portion of HIV's genetic material
The trial in India is part of a multi-country Phase I trial of tgAAC09 that is also underway in Europe, researchers in Germany and Belgium are testing the vaccine candidate in partnership with International AIDS Vaccine Initiative (IAVI).
tgAAC09 utilises a vaccine-making technology called recombinant adeno- associated viral vector (rAAV). This showed encouraging results in animals, protecting some of them from developing AIDS after they became infected with a HIV-like virus. Because what works in animals only provides a guide for what might work in humans, researchers now need to study tgAAC09 in clinical trials.
Dr N. K. Ganguly, director general of Indian Council of Medical Research (ICMR), heralded the trial as part of the Indian Government's commitment to combat the AIDS epidemic: "Our country is an emerging global leader in biomedical research. With this first trial, Indian scientists are making an important contribution that will bring the world a step closer to an AIDS vaccine."
Regulatory approval to test tgAAC09 in India was granted by the Drugs Controller General, the Health Ministry Steering Committee, the Genetic Engineering Approval Committee, the NARI Scientific Committee, the NARI Ethics Committee and the National Ethics Committee. For the trial in Germany and Belgium, approval was obtained from authorities in the countries.
Targeted Genetics Corp., a Seattle-based biotechnology company, and Columbus Children's Research Institute (CCRI) in Ohio designed the vaccine candidate in partnership with IAVI.